NCT05135520

Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen

A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who are planning multiport laparoscopic surgery for resection of kidney.

Detailed description

Study design: This is a prospective, randomized, single center trial. This clinical trial was approved by the Institutional Review Boards. Study process: All patients gave informed written consent after being informed of the details of the study. Subjects were randomized into either the experimental group (specimen removal through posterior vagina fornix incision) or control groups (specimen removal through extended abdominal incision). All participants underwent demographic and history taking, laboratory tests, a gynecologic examination to determine whether specimen removal through vagina is possible. To evaluate cosmesis, patient satisfaction and quality of life VAS (Visual Analogue Scale), SF-12 (Short Form-12) health survey, BIQ (Body Image Questionnaire) and POSAS (the Patient and Observer Scar Assessment Scale) will be sent to the patients 6 months after the surgery.

Conditions

• Urologic Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Transvaginal natural orifice specimen extraction (NOSE)	Under general anesthesia, patients who are planned to perform multiport laparoscopic surgery for resection of solid organs including kidney or bladder will undergo Transvaginal NOSE
PROCEDURE	Transabdominal specimen extraction	Under general anesthesia, patients who are planned to perform multiport laparoscopic surgery for resection of solid organs including kidney or bladder will undergo transabdominal specimen extraction with incision elongation

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-11-29
• Completion: 2023-11-29
• First posted: 2021-11-26
• Last updated: 2021-11-26